Senior NPI Optical Engineer Job San Carlos area,California USA,Engineering

Senior NPI Engineer – Optics

We are seeking a highly motivated hands‑on engineer with expertise in biotechnology hardware to join our instrument operations team. The role involves transferring subassembly designs from R&D, developing and refining manufacturing processes, troubleshooting hardware issues, and driving continuous improvements in production efficiency and reliability.

Responsibilities

Partner with R&D on new product introductions (NPI), ensuring smooth handoff from development to production
Design, develop, and optimize manufacturing processes for optical assemblies, including lens systems, illumination modules, laser subsystems, and camera integrations used in biotech instrumentation
Test, calibrate, and align optical modules, camera systems, and laser components to ensure performance meets design specifications and production tolerances
Develop and maintain calibration procedures, alignment protocols, and acceptance criteria for optical and laser subsystems
Establish and maintain process documentation including SOPs, work instructions, traveler sheets, and control plans
Develop and implement fixtures, tooling, and automated assembly aids to improve yield, repeatability, and throughput
Proficiency in design for manufacturability and reliability
Qualify new manufacturing processes and equipment; write and execute IQ/OQ/PQ protocols in compliance with ISO 13485 or FDA 21 CFR Part 820 requirements
Evaluate manufacturing processes by designing and conducting production failure modes and effect analysis
Support supplier qualification and incoming inspection criteria for optical components such as mirrors, prisms, filters, fiber optics, and coated optics
Assure product and process quality by designing testing methods
Prepare product and process reports by collecting, analyzing, and summarizing information and trends
Complete design and development projects by training and guiding technicians

Requirements

B.S. or M.S. in Mechanical Engineering, Optical Engineering, Manufacturing Engineering, or a related field

5–7 years of experience in a manufacturing or process engineering role, preferably in medical devices, diagnostics, or life sciences instrumentation

Working knowledge of optical principles: geometric optics, alignment techniques, fiber coupling, interferometry, or spectroscopy preferred

Familiarity with optical alignment and characterization equipment (autocollimators, interferometers, optical power meters, spectrometers)

Experience with precision assembly techniques in cleanroom or controlled environments

Proficiency with GD&T, engineering drawings, and CAD tools (Solid Works or equivalent)

Understanding of quality management systems — ISO 13485, FDA QSR, or GMP manufacturing environments

Hands‑on experience with statistical process control (SPC), DOE, and FMEA methodologies

Strong problem‑solving skills with a bias toward data‑driven decision‑making

Preferred Qualifications

Experience with fluorescence‑based imaging, flow cytometry, PCR instrumentation, or similar biotech platforms
Familiarity with automated optical inspection (AOI) or machine vision systems
Six Sigma Green Belt or Black Belt certification
Familiarity with Arena and Net Suite

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